Patenting genes

The U.S. Supreme Court on Thursday affirmed that there are at least a few things that humans cannot lay claim of ownership to, regardless of how closely they have studied a particular item. In this case, it was human genes – two in particular – that Myriad Genetics had located and sought patent protection for so as to ensure that its test for the genes would be the only one allowable on the market. In a unanimous decision, the Supreme Court said the company had overstepped what patent law allows. It was the right decision for many reasons.

First and most obvious among these is the fact that human genes – much like sunshine, blue sky and black bears – are not something that any individual and company can legitimately claim to have created. These are each examples of “naturally occurring phenomena” that came about through processes far beyond the capability of laboratory geneticists or inventors. Allowing a patent on such creations would be an overreach by any definition of the “creation, invention and discovery,” the Patent Act requires in order for a claim to pass muster. Myriad’s justification for its claim was that its scientists isolated the genes – BRCA1 and BRCA2 – and spent significant resources understanding the implications for those who carry them, primarily that these individuals may face an increased risk for breast cancer. That is all important work that Myriad has a valid interest in protecting, but claiming ownership of the genes themselves goes too far.

The court recognizes the balance between encouraging scientific discovery and protecting products of nature from claims of ownership, and makes clear the distinction between human genes that occur on their own and those created by scientists. The latter, the decision holds, are subject to patent claims, while the former are not, regardless of the methods by which they are discovered, isolated or understood. And because those methods used by Myriad were neither in question nor particularly groundbreaking, the court was not interested in extending extra protection for Myriad’s work.

“Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents,” Justice Clarence Thomas wrote for the court. This suggests that while Myriad was first to the finish line on this particular gene study, it was not on to a new line of inquiry, invention or discovery that is at the heart of patent law.

What Myriad appeared to be attempting was to lock up access to critical scientific knowledge, making itself the sole source of information about the BRCA1 and BRCA2 genes. That is antithetical to the notion of science, which is an ever-evolving concept that builds on what has come before to create new, broadened, refined, revised or more complex understandings. The court was right to acknowledge the importance of that process, the challenge in balancing intellectual property rights against the Patent Act’s stated commitment to encouraging innovation and the limits of how discovery and invention are defined.